Design controls designates the application of a formal
methodology to the conduct of
product development activities.
It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g.
medical devices).
Medical devices
Since 1990, the
Food and Drug Administration (FDA) has required that
medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires:
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Design and development planning
A design is a plan or specification for the construction of an object or system or for the implementation of an activity or process or the result of that plan or specification in the form of a prototype, product, or process. The verb ''to design'' ...
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Design input, including intended use and
user needs (also known as customer attributes)
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Design output, including evaluation of conformance to design input requirements through:
** Design verification confirming that the design output meets the design input requirements ("did we design the device right?")
** Design validation ensuring that the devices conform to defined user needs and intended uses ("did we design the right device?")
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Design review
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Design transfer ensuring that the device design is correctly translated into production specifications
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Design changes
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Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.
The
Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The
Medical Devices Regulation (MDR (EU) 2017/745), replacing the MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information of a technical documentation for a medical device.
ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.
The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of
efficacy
Efficacy is the ability to perform a task to a satisfactory or expected degree. The word comes from the same roots as ''effectiveness'', and it has often been used synonymously, although in pharmacology a pragmatic clinical trial#Efficacy versu ...
and safety.
Design input
Examples of design input:
References and external links
* 21 CFR 820.30 on the FDA websit
* MDD 93/42/EE
References
{{DEFAULTSORT:Design Controls
Design
Food and Drug Administration
Regulation of medical devices